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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Lightspeed 16 CT

GE Healthcare

Class I - Dangerous

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Jul 17, 2015 Other Medical Devices Nationwide View Details →

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

Stryker Howmedica Osteonics

Class I - Dangerous

it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

Jun 25, 2015 Implants & Prosthetics View Details →

PET Discovery LS

GE Healthcare

Class I - Dangerous

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Jul 17, 2015 Other Medical Devices Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Synthes (USA) Products

Class I - Dangerous

The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.

Aug 31, 2015 Other Medical Devices Nationwide View Details →

PET Discovery ST 16

GE Healthcare

Class I - Dangerous

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Jul 17, 2015 Other Medical Devices Nationwide View Details →

Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

Fujifilm Medical Systems U.S.A.

Class I - Dangerous

The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.

Jun 30, 2015 Other Medical Devices Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.

Resource Optimization & Innovation

Class I - Dangerous

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Aug 19, 2015 Surgical Instruments View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.

Brainlab AG

Class I - Dangerous

Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.

Aug 18, 2015 Surgical Instruments Nationwide View Details →

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

Siemens Healthcare Diagnostics

Class I - Dangerous

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Aug 24, 2015 Diagnostic Equipment Nationwide View Details →

ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.

Edwards Lifesciences

Class I - Dangerous

The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.

Aug 26, 2015 Infusion Pumps Nationwide View Details →

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

Fujifilm Medical Systems U.S.A.

Class I - Dangerous

Jun 30, 2015 Other Medical Devices Nationwide View Details →

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

Siemens Medical Solutions USA

Class I - Dangerous

A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

Aug 5, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

Bard Access Systems

Class I - Dangerous

Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the brochure.

Jul 20, 2015 Surgical Instruments View Details →